Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management (ANXYDOL)

Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management by Mobile Acute Pain Team

Screening of anxiogenic part of pain is an imperative during a medical pain consultation. The actual tools for evaluation of this specific part are complex and time consuming.

To date, it lacked a reliable and reproductive tool to quickly evaluate anxiety of patient in pain. The purpose of this study is to demonstrate the pertinence and validity of anxiety analogic visual scale by comparison with the actual reference the self-assessment questionnaire State Trait Inventory Anxiety Y-A form.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Other: Anxiety visual analog scale

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • CHU Rangueil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed and dated informed consent
• Male or female aged from ≥ 18 years old
• Perfect patient ability to understand and write French
• Patient with a pain threshold permitting a initial medication free consultation and completion of anxiety surveys.

Exclusion Criteria:

• Inability of patient to understand the study procedures and thus inability to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient; State-trait anxiety inventory Y-A form (STAI Y-A form) Anxiety visual analog scale evaluation(A-AVS).	Other: Anxiety visual analog scale; Anxiety visual analog scale is a test of evaluation of anxiety done by the patient, this scale do not include number and the patient have to place a coloured marker at the level indicating his anxiety feeling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pertinence of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score	The patient's inclusion take place during the only study participation day of the patient	Baseline
Evaluation of validity of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score	The patient's inclusion take place during the only study participation day of the patient	Baseline
Evaluation of pertinence of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with anxiety analogic visual scale score	The patient's inclusion take place during the only study participation day of the patient	Baseline
Evaluation of validity of anxiety analogic visual scale in systematic use as assessed by anxiety levels obtained with anxiety analogic visual scale score	The patient's inclusion take place during the only study participation day of the patient	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pain consultation impact on anxiety part of pain as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score	The patient's inclusion take place during the only study participation day of the patient	Baseline
Evaluation of pain consultation impact on anxiety part of pain as assessed by anxiety levels obtained with anxiety analogic visual scale score	The patient's inclusion take place during the only study participation day of the patient	Baseline
Evaluation of clinical utility of anxiety analogic visual scale in nursing care as assessed by anxiety levels obtained with State Trait of anxiety Y-A form score	The patient's inclusion take place during the only study participation day of the patient	Baseline
Evaluation of clinical utility of anxiety analogic visual scale in nursing care as assessed by anxiety levels anxiety analogic visual scale score	The patient's inclusion take place during the only study participation day of the patient	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Jean-Christophe FOISSAC, Nurse, CHU Rangueil

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Anxiety analogic visual scale; State Trait Inventory anxiety scale
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 12 560 07; 2013-A00451-44 (Other Identifier: France: Agence Nationale de Sécurité du Médicament)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No